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临床试验/NCT06459882
NCT06459882已完成不适用

Effect of Progressive Relaxation Exercises on Dyspnea and Comfort Level in Individuals With Chronıc Obstructive Lung Disease: A Randomized Controlled Study

Izmir Bakircay University2 个研究点 分布在 2 个国家目标入组 42 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
comfort level

研究概览

简要总结

The study is a randomised controlled experimental study conducted to examine the effect of progressive relaxation exercises on dyspnea and comfort level in individuals with chronic obstructive pulmonary disease. The study was conducted between January and August 2023 in the Internal Medicine Clinic of Izmir Urla State Hospital. Stratified and block randomisation method was used in the study and 42 patients, 21 intervention group and 21 control group, were completed. Patients in the intervention group received 30-minute progressive relaxation exercises for 6 weeks. Patients in the control group did not receive any intervention other than standard care practices. The data of the study were collected by face-to-face interview method using the Descriptive Information Form, Medical Research Council Dyspnea Scale, General Comfort Scale-Short Form and Patient Follow-up Form. Descriptive statistics, Shapiro Wilk test, Levene's test, Mauchly's W test, independent sample T test, Mann Whitney U test, dependent sample t test, Wilcoxon Signed Ranks test, Friedman test, Benferoni test and Fisher's Exact test were used to analyse the data obtained from the study. It was determined that the mean dyspnea level scores of the patients in the intervention group at week 6 were lower than the control group and this difference between the groups was statistically significant (p<0.05). It was determined that the decrease in the mean comfort level scores of the patients in the intervention group according to the follow-up periods was statistically significant (p<0.05). According to the results of the study, progressive relaxation exercises can be recommended as an effective nursing intervention to provide dyspnea management in patients with COPD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age and over
  • Inpatient treatment in the Internal Medicine Clinic of Izmir Urla State Hospital
  • Standardised Mini Mental Test score ≥24
  • Dyspnea severity ≥2 according to the MMRC dyspnoea scale
  • Diagnosed with Stage II and Stage III COPD according to GOLD criteria
  • Functional competence to participate in progressive relaxation exercises
  • Able to access and use a smartphone
  • COPD patients who agreed to participate in the study.

排除标准

  • Have any speech and hearing problems
  • Lung disease other than COPD, physical dependence and psychiatric illness diagnosed with
  • COPD patients in the acute exacerbation period.

结局指标

主要结局

comfort level

时间窗: baseline, week 3, and week 6

The scale consists of 28 items and three sub-dimensions: relief (9 items), relaxation (9 items) and overcoming problems (10 items). The lowest value of 1 indicates a low comfort level and the highest value of 6 indicates a high comfort level. In this study, the Cronbach alpha reliability coefficient of the scale was 0.74 for the intervention group and 0.82 for the control group.

dyspnea level

时间窗: baseline, week 3, and week 6

Medical Research Council Scale: MMRC is an easily applicable 5-item scale that shows similar results with lung function tests and arterial blood gas measurement and is recommended for use in determining the dyspnea levels of COPD patients in GOLD guidelines. The dyspnea level is graded between 0-4. A score of 0 indicates the absence of dyspnea, and an increase in the rating indicates an increase in the severity of dyspnea.

次要结局

未报告次要终点

研究者

发起方
Izmir Bakircay University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aysegul Celik

Asst. Prof., RN, MSc, PhD

Izmir Bakircay University

研究点 (2)

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